Bicuspid Valve Aortopathy Feasibility Study
Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
3 other identifiers
observational
500
1 country
6
Brief Summary
In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2017
CompletedSeptember 19, 2018
September 1, 2018
2.9 years
August 8, 2013
September 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in aortic area measured by MRI
Patients will have a baseline and follow up MRI per a specific protocol to measure area of the ascending thoracic aorta. All measurements will be performed by a core imaging lab
24 months
Secondary Outcomes (1)
Clinical events involving the aorta, including change in medical therapy
24 months
Study Arms (3)
Beta blocker therapy
Cohort will consist of those actively taking any beta blocker medication. Observation only.
ARB therapy
Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.
No therapy
Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.
Interventions
Eligibility Criteria
Patients with a bicuspid aortic valve.
You may qualify if:
- Bicuspid aortic valve
- Aortic measurement of 35 - 49 mm on prior imaging study
You may not qualify if:
- Prior aortic valve or thoracic aortic surgery
- Prior aortic dissection
- Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
- Severe aortic stenosis or regurgitation
- Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
- Anticipated pregnancy, surgery, or move outside the area within 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Emory Universitycollaborator
- University of Colorado, Denvercollaborator
- Baylor College of Medicinecollaborator
- University of California, Los Angelescollaborator
- Penn State Universitycollaborator
Study Sites (6)
University of California
Los Angeles, California, United States
University of Colorado
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State
Hershey, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 12, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2016
Study Completion
October 4, 2017
Last Updated
September 19, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share